Drug recall
FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth
FDA recall event 89449 · Class II · Envisiontec US Llc
Key facts
| Event ID | 89449 |
|---|---|
| Recall numbers | Z-0642-2022, Z-0643-2022 |
| Recalling firm | Envisiontec US Llc |
| Product type | Devices |
| Products | FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth, FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin |
| Initiation date | Jan 6, 2022 |
| Report date | Feb 23, 2022 |
| City | Dearborn |
| State | MI |
| Country | United States |
| FEI number | 3009261582 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: